Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00606359
First received: January 21, 2008
Last updated: January 10, 2014
Last verified: January 2014

January 21, 2008
January 10, 2014
November 2007
February 2008   (final data collection date for primary outcome measure)
  • Anti-HA individual titers [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Individual titers ratio [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Seroconversion or significant increase [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606359 on ClinicalTrials.gov Archive Site
Safety: Adverse events in the first 21 days after each vaccination; Pre-listed reactions in the 7 days following each vaccination; Serious adverse events during the entire trial. [ Time Frame: 21 days following each vaccination ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

Primary Objective:

To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).

Secondary Objective:

To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine

The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza
  • Orthomyxoviridae Infections
  • Biological: Inactivated, split-virion influenza virus
    0.1 mL, Intradermal. 2 vaccinations 12 months apart
  • Biological: Inactivated, split-virion influenza virus
    0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
    Other Name: Vaxigrip®
  • Experimental: Study Group 1
    Intervention: Biological: Inactivated, split-virion influenza virus
  • Active Comparator: Study Group 2
    Intervention: Biological: Inactivated, split-virion influenza virus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
June 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to attend all scheduled visits and to comply with all trial procedures.
  • Subject with renal transplant for at least 6 months.
  • Subject with stable renal function, i.e. with a variation of creatinin value < 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation > 20 mL/min during the 3 months preceding inclusion.
  • Aged 18 to 59 years on the day of the screening visit.
  • Informed Consent Form signed.
  • Subject entitled to national social security.
  • Subject under immunosuppressive therapy.
  • For a woman, inability to bear a child or negative urine pregnancy test.
  • Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.

Exclusion Criteria:

  • Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
  • Breast-feeding.
  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
  • Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Blood or blood-derived products received in the past 3 months .
  • Any vaccination in the 4 weeks preceding the trial vaccination.
  • Vaccination planned in the 4 weeks following the trial vaccination.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
  • Previous vaccination against influenza in the preceding 6 months.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00606359
GID26
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP